inforMED
MalfunctionMQS

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Received Mar 19, 2013 · Event occurred Mar 14, 2013

Report 3021316 · MDR key 3021316

Device

Generic name

System, Hemodialysis

Model number

2008K2

Catalog number

*

Lot number

*

Product problems

  • Device Displays Incorrect Message

Patient

83 YR

  • No Information

Narrative

Description of Event or Problem

HEMODIALYSIS STARTED AT 0920. AT 0925 THE MACHINE INDICATED DIAL VALVE FAILURE 1 AND MACHINE WENT INTO BYPASS. PATIENT NOT RINSED BACK. MD IN ROOM. H&H DRAWN - NEW TUBING AND MACHINE SET UP. HD COMPLETED. PATIENT DISCHARGED. DISCUSSED WITH COMPANY REPRESENTATIVE. TEST RUN - COULD NOT DUPLICATE ALARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HEMODYALISIS.